All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.Even after several requests no further information regarding this incident has been submitted.Without information regarding the occurrence of the break this case cannot be investigated.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
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